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A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings

BACKGROUND: To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth inte...

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Autores principales: Maar, Marion A, Yeates, Karen, Perkins, Nancy, Boesch, Lisa, Hua-Stewart, Diane, Liu, Peter, Sleeth, Jessica, Tobe, Sheldon W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5418524/
https://www.ncbi.nlm.nih.gov/pubmed/28428165
http://dx.doi.org/10.2196/mhealth.7044
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author Maar, Marion A
Yeates, Karen
Perkins, Nancy
Boesch, Lisa
Hua-Stewart, Diane
Liu, Peter
Sleeth, Jessica
Tobe, Sheldon W
author_facet Maar, Marion A
Yeates, Karen
Perkins, Nancy
Boesch, Lisa
Hua-Stewart, Diane
Liu, Peter
Sleeth, Jessica
Tobe, Sheldon W
author_sort Maar, Marion A
collection PubMed
description BACKGROUND: To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. OBJECTIVE: Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. METHODS: Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. RESULTS: Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. CONCLUSIONS: Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. TRIAL REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege)
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spelling pubmed-54185242017-05-17 A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings Maar, Marion A Yeates, Karen Perkins, Nancy Boesch, Lisa Hua-Stewart, Diane Liu, Peter Sleeth, Jessica Tobe, Sheldon W JMIR Mhealth Uhealth Original Paper BACKGROUND: To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. OBJECTIVE: Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. METHODS: Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. RESULTS: Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. CONCLUSIONS: Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. TRIAL REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege) JMIR Publications 2017-04-20 /pmc/articles/PMC5418524/ /pubmed/28428165 http://dx.doi.org/10.2196/mhealth.7044 Text en ©Marion A Maar, Karen Yeates, Nancy Perkins, Lisa Boesch, Diane Hua-Stewart, Peter Liu, Jessica Sleeth, Sheldon W Tobe. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.04.2017. https://creativecommons.org/licenses/by/2.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/ (https://creativecommons.org/licenses/by/2.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Maar, Marion A
Yeates, Karen
Perkins, Nancy
Boesch, Lisa
Hua-Stewart, Diane
Liu, Peter
Sleeth, Jessica
Tobe, Sheldon W
A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title_full A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title_fullStr A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title_full_unstemmed A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title_short A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings
title_sort framework for the study of complex mhealth interventions in diverse cultural settings
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5418524/
https://www.ncbi.nlm.nih.gov/pubmed/28428165
http://dx.doi.org/10.2196/mhealth.7044
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